Duns Number:827716437
Device Description: SecurePortIV is a catheter securement adhesive to be applied as a film forming securement SecurePortIV is a catheter securement adhesive to be applied as a film forming securement and sealant at the point of vascular access catheter skin entry.
Catalog Number
SP-015V
Brand Name
SecurePortIV
Version/Model Number
SP-015V
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K170505,K170505
Product Code
NZP
Product Code Name
Sealant, Microbial
Public Device Record Key
be015aba-5e81-4ba2-bb85-1d08a8d32a16
Public Version Date
July 22, 2019
Public Version Number
6
DI Record Publish Date
January 30, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |